Kidney TransplantationMANGUENCT03503461
Major Activation Of NCC in Graft Urinary Exosomes
An observational study of Kidney Transplantation, run by University Hospital, Bordeaux at 2 sites in 2 countries.
Trial summary
Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- exosomes analysis
- How many people
- 67 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jun 2018to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Kidney transplant group is a population of transplant subjects treated with anticalcineurin since 3 months. Control group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant.
Who may be able to join
- Age≥18years
- Recipients three months after kidney transplantation using calcineurin inhibitors
- Glomerular Filtration Rate>15ml.mn.m2 CKD-EPI
- Renal ultrasound underwent before inclusion
- No opposition at participating at the research
- No previous transplantation
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- Age≥18years
- No hypertension
- No metabolic disorders (dysnatremia, dyskaliemia, acidosis or alkalosis)
- No opposition at participating at the research
Who cannot join
- Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion
- Graft artery stenosis with indication of interventional radiology or surgery
- For control group :
- Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse
Bordeaux, 33000
Reunion1 site
Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales
Saint-Denis, 97400
About this study
Official title: Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors
Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.
Read the detailed description
Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. Gordon syndrome is a rare genetic disorder where NCC cotransporter is overactivated and cause hypertension, metabolic acidosis and tendency to hyperkaliemia. Few studies evaluated NCC expression by exosomes techniques in human kidney transplant, and mostly compared NCC expression in specific subpopulation (for example with or without hypertension). Thus, prevalence of NCC activation by CNI is unknown. To determine it, we will include prospective patients in Bordeaux and la Réunion who undergo urine and blood tests three months after transplantation, and a control group with no transplantation and no use of CNI. First, we will compare kidney recipients and control and use immunoblot to quantify NCC expression in urinary exosomes to identify the population of transplanted with a high activation. Then, we will analyze the relationship between NCC activation and clinicobiological features of Gordon's syndrome.
- Conditions
- Kidney Transplantation
- Being tested
- exosomes analysis
- Keywords
- Calcineurin inhibitors, hypertension, kidney transplant, acidosis, Gordon syndrome
- Medical subject headings
- Hypertension, Acidosis, Gordon syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomes analysisOther
Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Control group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant. Exosome analysis will be perform in urine sample. Receives: Other: exosomes analysis | |
| Kidney transplants group | Kidney transplants group is a kidney transplant subjects population 3 months ago. Exosome analysis will be perform in urine sample collected at 3 months. Receives: Other: exosomes analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCC cotransporter expression
Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.
Measured: Inclusion day
Secondary outcomes (2)
Phosphorylated NCC cotransporter expression
Dosage of phosphorylated NCC cotransporter expression in urinary exosomes samples in both groups.
Measured: Inclusion day
pendrine expression in kidney transplant group
Dosage of pendrine expression in urinary exosomes samples in kidney transplant group.
Measured: Inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start21 Jun 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503461
- Sponsor's protocol ID
- CHUBX 2018/08
- Acronym
- MANGUE
- Status last verified
- Nov 2018
- First submitted
- 11 Apr 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors
- ClinicalTrials.gov ID
- NCT03503461
- Acronym / sponsor ID
- MANGUE / CHUBX 2018/08
- Conditions
- Kidney Transplantation
- Keywords
- Calcineurin inhibitors, hypertension, kidney transplant, acidosis, Gordon syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.
Detailed description
Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. Gordon syndrome is a rare genetic disorder where NCC cotransporter is overactivated and cause hypertension, metabolic acidosis and tendency to hyperkaliemia. Few studies evaluated NCC expression by exosomes techniques in human kidney transplant, and mostly compared NCC expression in specific subpopulation (for example with or without hypertension). Thus, prevalence of NCC activation by CNI is unknown. To determine it, we will include prospective patients in Bordeaux and la Réunion who undergo urine and blood tests three months after transplantation, and a control group with no transplantation and no use of CNI. First, we will compare kidney recipients and control and use immunoblot to quantify NCC expression in urinary exosomes to identify the population of transplanted with a high activation. Then, we will analyze the relationship between NCC activation and clinicobiological features of Gordon's syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: exosomes analysisControl group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant. Exosome analysis will be perform in urine sample. |
| Kidney transplants group | – | Other: exosomes analysisKidney transplants group is a kidney transplant subjects population 3 months ago. Exosome analysis will be perform in urine sample collected at 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant group is a population of transplant subjects treated with anticalcineurin since 3 months. Control group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant.
Key inclusion criteria (10 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomes analysisPerform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group. | Other | Control group, Kidney transplants group |
Primary outcome
NCC cotransporter expression
Time frame: Inclusion day
Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.
2 secondary outcomes
Phosphorylated NCC cotransporter expression
Time frame: Inclusion day
pendrine expression in kidney transplant group
Time frame: Inclusion day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by University Hospital, Bordeaux at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCC cotransporter expression (time frame: Inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.